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Quality and Technical Agreement

Half-day
Life Sciences

This interactive course with workshops is designed to bring you up-to-date with regulatory requirements regarding Quality and Technical Agreements. You get to know a practical approach, applicable for contract givers and acceptors, to establish, implement and update these agreements.

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Audience

Functions involved in the establishment, implementation and updating of Quality and Technical Agreements or auditing of implemented arrangements

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 12:00
Course
10:00 - 10:30
Networking & closing
Price
€ 799

per participant    (excl. VAT)

✓ Exclusive learning approach

✓ Personal course documentation

Lunch, water, coffee & tea

Networking

✓ Course certificate after completion

Location

Quastion Learning Center (Qplus consult BVBA)

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

Your Trainer
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Kristina Bindus

  • Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.

  • Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.

  • Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.

  • Kristina is specialized in online medical communication: webcast, webinar and e-learning.

  • She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.

  • Kristina has an extensive experience in Quality & Pharmacovigilance.

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    Kristina Bindus has over 25 years of experience in QA, RA, Auditing and Pharmacovigilance within leading (bio)pharmaceutical and medical devices companies.
Program

Roadmap for a practical Approach

  • How to start and what do I need?

  • Who is involved?

  • Which activities require a Quality and Technical Agreement?

GMP and GDP Requirements

  • Duties and responsibilities of contract giver and contract acceptor

  • Outsourced activities

  • Correctly defined, agreed and controller contracted services

  • Suppliers

Structure & Content of Agreements

  • How to create own template

  • Role of QA and Qualified Person/Responsible Person for GDP

  • Basic principles of contractual obligations and responsibilities

  • Content of agreement

  • Definitions

  • Timelines and targets

  • Service/commercial agreements vs Quality and Technical Agreements

Common Pitfalls and how to avoid them

  • Expectations of the Health Authorities

  • The most common pitfalls and tools to avoid them

  • Implementation of the Quality and Technical Agreement arrangements into your own quality system

  • How to evaluate and document your compliance to the agreed arrangements

Duties and Responsibilities of Contract Giver and Contract Acceptor

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Quality and Technical Agreement

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Quastion Learning Center

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

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